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According to allegations raised in a recently filed product liability lawsuit, side effects of Elmiron caused a Kentucky woman to suffer irreversible retina damage which has left her with permanent vision problems after years of taking the bladder drug for treatment of interstitial cystitis.
Brenda Perkins filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on February 18, alleging Johnson & Johnson, its’ Janssen Pharmaceuticals subsidiary, as well as Teva Pharmaceuticals and Alza Corporation, failed to adequately warn users and the medical community about the risk of vision loss and retinal damage that may be caused by Elmiron.
The drug makers have marketed Elmiron as a safe and effective treatment for interstitial cystitis for decades, without providing any warnings about the vision risks or importance of monitoring for retina changes until last year, when updated warnings about the Elmiron eye risks were added to the label for the first time.
Although independent studies and case reports have described cases of irreversible retina damage from Elmiron for years, many doctors remained unaware of the connection until recently, leading many users to continue taking the medication for years after they developed signs or symptoms of vision side effects, further worsening the permanent damage to the retina.
Perkins indicates she began taking Elmiron in 2012 for the treatment of interstitial cystitis and bladder pain, continuing to use the drug until 2020. However, the lawsuit indicates she experienced a number of symptoms of vision problems and retinal changes, and now has been left with permanent damage known as maculopathy.
“Plaintiff’s prescribing physicians were given no warning by Defendants of the serious risk of vision threatening retinal changes, including vision loss and maculopathy posed by Elmiron,” according to the complaint. “Plaintiff was given no warning by Defendants of the need for ophthalmologic monitoring before taking, while taking and after discontinuing Elmiron,” noting in the lawsuit that further vision changes may continue to progress even though she is no longer taking the drug.
The case joins a growing number of Elmiron retina damage lawsuits being pursued by former users, alleging permanent injuries may have been avoided if earlier warnings had been provided by the drug makers.
Given common allegations raised in dozens of complaints brought throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated pretrial proceedings last month, centralized the cases before one judge in the U.S. District Court for the District of New Jersey.
As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected several hundred, if not thousands, of similar complaints may be brought on behalf of former users nationwide.
Following coordinated discovery and a series of “bellwether” trials likely to be held in the federal MDL, if the drug makers fail to negotiate Elmiron settlements for users left with vision problems, the complaints filed by Baum and other plaintiffs will be remanded back to U.S. District Courts nationwide in future years, for individual jury trials.